System for fusing joints

ABSTRACT

A method of fusing a joint between two bones, comprising boring a hole through one of the bones across the joint therebetween and into the other bone, placing the leading end of a screw into the hole, where the screw has a threaded region having a pitch that is larger toward a leading end of the screw and smaller toward a trailing end of the screw, and driving the screw into the bone until the threaded region spans the joint.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.09/483,076, filed Jan. 14, 2000 now abandoned. In turn. U.S. patentapplication Ser. No. 09/483,076, filed Jan. 14, 2000 is acontinuation-in-part of U.S. patent application Ser. No. 09/305,841,filed May 5, 1999, issued as U.S. Pat. No. 6,017,347 on Jan. 25, 2000,which is a continuation-in-part of U.S. patent application Ser. No.09/157,783, filed Sep. 21, 1998, issued as U.S. Pat. No. 6,120,505 onSep. 19, 2000, which is a continuation-in-part of U.S. patentapplication Ser. No. 08/457,624, filed Jun. 1, 1995, issued as U.S. Pat.No. 5,810,825 on Sep. 22, 1998. U.S. patent application Ser. No.09/483,076, filed Jan. 14, 2000 is also a continuation-in-part of U.S.patent application Ser. No. 09/375,306, filed Aug. 16, 1999, issued asU.S. Pat. No. 6,299,615 on Oct. 9, 2001, which is a continuation-in-partof U.S. patent application Ser. No. 09/019,135, filed Feb. 5, 1998,issued as U.S. Pat. No. 5,976,134 on Nov. 2, 1999, Which is acontinuation-in-part of U.S. patent application Ser. No. 08/847,820,filed Apr. 28, 1997 now abandoned, which is a continuation-in-part ofU.S. patent application Ser. No. 08/587,210, filed Jan. 11, 1996, nowissued as U.S. Pat. No. 5,624,440 on Apr. 29, 1997, and also acontinuation-in-part of U.S. patent application Ser. No. 08/622,368,filed Mar. 26, 1996, now issued as U.S. Pat. No. 5,665,087 on Sep. 9,1997, and a continuation-in-part of U.S. patent application Ser. No.09/318,437, filed May 25, 1999, issued as U.S. Pat. No. 6,162,224 onDec. 19, 2000 and U.S. patent application Ser. No. 09/318,669, filed May25, 1999, issued as U.S. Pat. No. 6,171,309 on Jan. 9, 2001. The '224and '309 patents are continuations-in-part of U.S. patent applicationSer. No. 08/636,326, filed Apr. 22, 1996, now issued as U.S. Pat. No.5,662,649 on Sep. 2, 1997. U.S. patent application Ser. No. 09/483,076,filed Jan. 14, 2000 is also a continuation-in-part of U.S. patentapplication Ser. No. 08/715,017, filed Sep. 17, 1996, now issued as U.S.Pat. No. 5,658,283 on Aug. 19, 1997, and a continuation-in-part of U.S.patent application Ser. No. 08/759,075, filed Dec. 2, 1996, now issuedas U.S. Pat. No. 5,697,934 on Dec. 16, 1997, and also acontinuation-in-part of U.S. Des. patent application Ser. No. 29/063,695now U.S. Pat. No. D404,128, filed Dec. 13, 1996, and acontinuation-in-part of U.S. patent Application No. 08/773,968, filedDec. 26, 1996, now issued as U.S. Pat. No. 5,702,472 on Dec. 30, 1997,and also a continuation-in-part of U.S. patent application Ser. No.09/034,046, filed Mar. 3, 1998, issued as U.S. Pat. No. 5,964,768 onOct. 12, 1999, which is a continuation-in-part of U.S. patentapplication Ser. No. 08/781,471, filed Jan. 10, 1997 now U.S. Pat. No.5,871,486, and also a continuation-in-part of U.S. patent applicationSer. No. 08/792,988, filed Feb. 3, 1997 now U.S. Pat. No. 5,868,789.U.S. patent application Ser. No. 09/483,076, filed Jan. 14, 2000 is alsoa continuation-in-part of 09/157,783, filed Sep. 21, 1998 now U.S. Pat.No. 6,120,505, which is a continuation-in-part of U.S. patentapplication Ser. No. 08/457,624, filed Jun. 1, 1995, now issued as U.S.Pat. No. 5,810,825 on Sep. 22, 1998. U.S. patent application Ser. No.09/483,076, filed Jan. 14, 2000 is also a continuation-in-part of U.S.patent application Ser. No. 08/986,717, filed Dec. 8, 1997, issued asU.S. Pat. No. 5,994,721 on Aug. 31, 1999, and also acontinuation-in-part of U.S. patent application Ser. No. 09/093,415,filed Jun. 8, 1998, issued as U.S. Pat. No. 6,001,099 on Dec. 14, 1999.U.S. patent application Ser. No. 09/483,076, filed Jan. 14, 2000 is alsoa continuation-in-part of U.S. patent application Ser. No. 09/216,316,filed Dec. 18, 1998, issued as U.S. Pat. No. 6,030,162 on Feb. 29, 2000,and U.S. patent application Ser. No. 09/263,141, filed Mar. 5, 1999,issued as U.S. Pat. No. 6,077,271 on Jun. 20, 2000 which claims priorityfrom U.S. Provisional Patent Application Ser. No. 60/077,168, filed Mar.6, 1998. All of the above patents and applications are herebyincorporated by reference.

FIELD OF THE INVENTION

The present invention relates generally to a bone screw for drawingtogether bone fragments separated by a fracture and more particularly tosuch a screw which draws the bone fragments together as a result ofdifferent-pitched threads on the screw.

BACKGROUND OF THE INVENTION

In healing bone fractures it is desirable to compress the fractures sothat the fractured surfaces are pressed against one another. In theprior art, bone screws have been used to draw the fractured surfacestogether and thereby optimize the healing process.

A number of prior art bone screws have been constructed in a fashionresembling wood screws. For example, some prior art bone screws includea threaded distal portion and a head with a relatively long unthreadedshank disposed between the head and the distal portion. A drill is usedto create a bore through the fracture and the screw is threaded into theremote bone fragment with the head of the screw compressing the nearfragment tightly against the remote bone fragment.

Other bone screws are threaded along the length thereof, thus requiringa first drill bit to create a bore in both bone fragments extendingacross the fracture and a second bit to drill a larger bore in the nearbone fragment so that the screw threads do not engage the near bonefragment. Thereafter, the screw is tightened in the same manner asdescribed above in connection with the screw having an unthreaded shank,thereby compressing the fragments together.

The operation of two prior art headed lag screws is illustrated in FIGS.8A–10D. The operation of a lag screw A₁ with a head B₁ and a shank C₁ isshown in FIG. 8A–D. Shank C₁ of screw A₁ includes threads D₁ at thedistal end and an unthreaded region E₁ proximal to head B₁. The pitch ofthreads D₁ is constant. FIG. 8A shows screw A₁ partially engaged in abore F₁ in a near bone fragment G₁. The diameter of bore F₁, is lessthan the diameter of threads D₁ and therefore the threads engage thewalls of the bore as the screw is twisted in. FIG. 8B shows screw A₁ asit starts threading into a bore H₁ in a remote bone fragment I₁. At thispoint threads D₁ are engaged in both bores and moving forward at thesame speed in both fragments so no compression between the fragments isachieved. Head B₁ has reached the top of fragment G₁ in FIG. 8C, asindicated schematically by the radiating “force” lines. Since threads D₁are no longer engaged in fragment G₁, screw A₁ rotates freely in thefragment without being drawn forward therein. Subsequent rotation ofscrew A₁ draws fragment I₁ further up the screw. Because head B₁prevents fragment G₁ from moving further up screw A₁, fragment I₁ isdrawn up against fragment G₁ and compression between the fragments isachieved as shown in FIG. 8D, with the head pulling down on the nearfragment and the threads pulling up on the remote fragment.

The importance of the unthreaded region of screw A₁ is illustrated inFIGS. 9A–d. A lag screw A₂ including a head B₂ and a shank C₂ is shownpartially engaged in a bore F₂ in a near fragment G₂ in FIG. 9A. ShankC₂ includes threads D₂ running the entire length with no unthreadedregion such as E₁ on screw A₁. Rotating screw A₂ causes it to be drawnthrough fragment G₂ and pass into a bore H₂ in a remote fragment I₂, asshown in FIG. 9B. Further rotation of screw A₂ brings head B₂ downagainst the upper surface of fragment G₂. See FIG. 9C. At this point,threads D₂ are still engaged in bore F₂ of fragment G₂ and theinteraction of the head on the surface of fragment G₂ impedes thefurther rotation of screw A₂. To have additional rotation, head B₂ wouldhave to be drawn down into fragment G₂ or the portion of threads D₂ infragment G₂ would have to strip out. Therefore a fully threaded screw,such as screw A₂, would not be preferred for use in the fragment andbore configuration of FIGS. 9A–D.

The proper bore configuration for using screw A₂ is illustrated in FIGS10A–D. As shown in FIG. 10A, bore F₂ in fragment G₂ is enlarged to allowthreads D₂ of screw A₂ to pass freely through the bore. Screw A₂therefore slips into bore F₂ until it reaches fragment I₂. At thatpoint, threads D₂ engage the walls of bore H₂ and draw screw A₂ downinto fragment I₂. See FIGS. 10B–C. When head B₂ reaches the uppersurface of fragment G₂, further rotation causes fragment I₂ to be drawnup into contact with fragment G₂ as shown in FIGS. 10C–D. No bindingoccurs between head B₂ and threads D₂ in the near fragment because ofthe large bore in fragment G₂, and the screw functions as intended todraw the two fragments together.

FIGS. 11A–12D illustrate the effect of substituting headless screws inthe place of lag screws A₁ and A₂. FIG. 11A, in particular, shows aheadless screw A₃ partially installed in a bore F₃ in a near fragmentG₃. Screw A₃ includes threads D₃ extending along its entire length. Thepitch of threads D₃ is constant. FIG. 11B shows screw A₃ extendingthrough fragment G₃ and just entering a bore H₃ in a remote fragment I₃.FIG. 11C shows screw A₃ advanced further into fragment I₃. It should benoted that, since the pitch of threads D₃ is constant, screw A₃ movesforward in fragments G₃ and I₃ by the same amount with each rotation. Asshown in FIG. 11D, screw A₃ will pass through both fragments withoutaltering their relative spacing or compressing them together. Thus, aheadless screw such as screw A₃ will not work to draw the fragmentstogether in the same way as lag screws A₁ and A₂.

A variation of screw A₃ is shown at A₄ in FIG. 12A. Screw A₄ includesthreads D₄ of constant pitch extending along its entire length anddiffers from screw A₃ in that it tapers from a smaller outside diameterat the leading end to a larger outside diameter at the trailing end.Screw A₄ is shown because it incorporates tapering, which is one of thefeatures of the present invention, however, it is unknown whether such ascrew is found in the prior art. Screw A₄ is shown partially installedin a bore F₄ in a near fragment G₄ in FIG. 12A. As screw A₄ is rotated,it moves through fragment G₄ and into a bore H₄ in a remote fragment I₄,as shown in FIG. 12B. Subsequent rotation simply carries screw A₄further into and through fragment I₄ without any effect on the spacingbetween the fragments. See FIGS. 12C–D. With a constant pitch thread,such as found on thread D₄, the taper does not facilitate compression.Taper may, however, make a screw easier to start in a small pilot holeor even without a pilot hole. The threaded portion of many wood screwsfollows this general format, tapering to a sharp point, to allowinstallation without a pilot hole.

It can be seen from the above discussion that a headless screw ofconstant pitch does not achieve the desired compressive effect betweenthe two fragments as will a lag screw with a head. It is, however,possible to draw two fragments together with a headless screw if it hasvarying pitch. FIG. 13A shows a headless screw A₅ with threads D₅ formedalong its entire length. Such a screw is shown in U.S. Pat. No. 146,023to Russell. The pitch of threads D₅ varies from a maximum at the leadingend to a minimum at the trailing end. It is expected that such a screwmoves forward upon rotation in a fragment according to the approximateaverage pitch of the threads engaged in the fragment. Screw A₅ is shownin FIG. 13A with the leading threads engaged in a bore F₅ in a nearfragment G₅. Rotation of screw A₅ causes it to move forward into andthrough fragment G₅ and into a bore H₅ in a remote fragment I₅, as shownin FIG. 13B. Additional rotation after the leading threads engagefragment I₅ causes the two fragments to be drawn together. See FIGS.13C–D This is because the average pitch of the threads in fragment I₅ isgreater than the average pitch of threads in fragment G₅. Since thescrew moves forward in each fragment with each 360° rotation by anamount roughly equal to the average pitch of the threads in thatfragment, each rotation will move the screw forward further in fragmentI₅ than in fragment G₅. This effect will gradually draw the fragmentstogether as the screw moves forward. Depending on the initial spacingbetween the fragments, they can make contact either before or after thetrailing end of the screw has entered fragment G₅. It should be notedthat screw A₅, in contrast to constant pitch screws such as screws A₁and A₂, can be used to separate fragments G₅ and I₅ by simply reversingthe rotation.

One drawback of a screw such as shown in Russell is the stripping orreaming of the female threads created in the bore by the leading threadsas the trailing threads follow. Because the pitch changes along thelength of the screw, no thread exactly follows the thread directly infront of it. Rather, each thread tends to cut its own new path whichonly partially overlaps the path of the thread ahead of it. Thus, thetrailing threads tend to ream out the female threads in the bore made bythe leading threads. This effect reduces the grip of the trailingthreads and therefore the overall compressive force available to urgethe fragments together.

FIG. 14A shows a headless screw A₆, such as disclosed in U.S. Pat. No.4,175,555 to Herbert, that offers one solution to the problem of reamingof threads. As noted in the Herbert patent, bone screws having headssuffer from several disadvantages A including concentrated loads beneaththe screw head and the protrusion of the screw head itself after thescrew is installed. Several other shortcomings of the standard type ofbone screw are detailed in the Herbert patent.

Screw A₆, as per Herbert, includes a shank C₆ with leading threads J₆ atthe leading end, trailing threads K₆ at the trailing end and anunthreaded region E₆ separating the leading and trailing threads.Threads J₆ and K₆ each have fixed pitch, but leading threads J₆ have alarger pitch and smaller outside diameter than trailing threads K₆. FIG.14A shows leading threads J₆ of screw A₆ installed in a bore F₆ of anear fragment G₆. It should be noted that threads J₆ do not engage thewalls of bore F₆, the bore having been bored large enough to allowleading threads J₆ to pass freely. As the screw moves forward, theleading threads engage a bore H₆ in a remote fragment I₆. See FIG. 14B.The diameter of bore H₆ is adapted so that leading threads J₆ engage thewalls. Meanwhile, at the trailing end of the screw, trailing threads K₆start to engage the walls of bore F₆, which has been bored to anappropriate diameter therefor.

As soon as trailing threads K₆ are engaged in bore F₆ and leadingthreads J₆ are engaged in bore H₆, the two fragments start drawingtogether. See FIG. 14C. Further rotation of screw A₆ completes theprocess of moving the two fragments together as shown in FIG. 14D. ScrewA₆ operates on the same general principle as screw A₅, except that theaverage pitch of the threads in the remote and near fragments is simplythe pitch of the leading and trailing threads, respectively. Forinstance, if the pitch of the leading threads is 0.2 inches and thepitch of the trailing threads is 0.1 inches, each rotation of screw A₆will move it 0.2 inches further into fragment H₆, but only 0.1 inchesfurther into fragment I₆, thus moving the fragments 0.1 inches closertogether.

The Herbert screw overcomes at least one of the drawbacks of the Russellscrew, the reaming of female threads by subsequent threads on the screw,but at the same time suffers from a number of other disadvantages. Inthe Herbert screw, the leading threads have a smaller diameter than thetrailing threads. This is necessary to permit the leading threads topass through the relatively large bore in the near bone fragment andengage the smaller bore in the remote bone fragment. The larger trailingthreads then engage the larger bore in the near bone fragment. As aresult of this arrangement, any stripping of the threads cut into thebones during installation of the screw occurs in the remote bone. If thestripping occurred in the bore in the near bone fragment, a screw havinga head thereon could still be used to compress the fracture even thoughthe near bore was stripped; however, when stripping occurs in the borein the remote bone, a standard screw with the head thereon cannot beused and another bore must be drilled.

Further, the Herbert screw must be correctly positioned, i.e., it isimperative that the fracture intersect the unthreaded central portion ofthe Herbert bone screw when the same is installed. Thus, the Herbertscrew is not suitable for treating fractures that are very near thesurface of the bone where the hole is to be drilled. In addition,because the Herbert screw is not threaded entirely along the lengththereof, the purchase obtained by the screw in the bone is not as goodas with a screw threaded along the entire length. Also, two bores ofdifferent sizes must be drilled to install the Herbert screw rather thana single bore.

Yet another problem with the Herbert screw is the stripping that canoccur if additional tightening occurs after the screw has drawn the bonefragments together. While the bone fragments are being drawn together,trailing threads K₆ all follow a single path through the near fragment.Similarly, leading threads J₆ all follow a single path through theremote fragment. When, however, the bone fragments make contact, the twosets of threads can no longer move independently. Further rotation ofthe Herbert screw after contact between the fragments can cause theleading threads to strip out as they attempt to move forward through thedistal bone fragment faster than the trailing threads will allow. SeeThe Herbert Bone Screw and Its Applications in Foot Surgery The Journalof Foot and Ankle Surgery, No. 33, Vol 4., 1994, pages 346–354 at page346, which reports on a study that found compression of 10 kg. afteronly two complete turns of the trailing threads engaged in the near bonefragment. Each subsequent revolution lead to a decrease in compressiveforce. Thus, care must be taken not to over-tighten the Herbert screw.

In addition to drawing two bone fragments together to repair fractures,it is sometimes desirable to draw together two bones for fusing the sametogether in connection with arthrodesis of the interphalangeal joints.This procedure is sometimes indicated with symptoms of pain orinstability in the finger joints. The purpose is to immobilize and drawtogether adjacent bones across a joint to cause them to fuse togetherthereby preventing further movement at the joint.

In one prior art procedure for immobilizing the distal interphalangealjoint (DIP), axial bores are drilled in the articular surfaces of thedistal and proximal phalanges. The bore in the distal bone issufficiently large to receive without threading a screw which isinserted therein via an incision in the tip of the finger. The screwthreadably engages the bore in the proximal bone and when the screw headis tightened against the distal end of the distal bone, the two bonesare compressed together. After several weeks, the bones fuse together. Asecond procedure to remove the screw must be performed because the headof the screw will cause discomfort in the finger pad if the screw is notremoved.

This procedure is undesirable because it requires two separatesurgeries. Katzman, et al., Use of a Herbert Screw for InterphalangealJoint Arthrodesis, Clinical Orthopedics and Related Research, No. 296pages 127–132 (November 1993), describes use of the screw disclosed inthe Herbert patent in procedures for interphalangeal joint arthrodesis.

Many of the above-discussed disadvantages associated with using aHerbert screw to compress a fracture are also present when the Herbertscrew is used for interphalangeal joint arthrodesis.

It would be desirable to provide a headless bone screw which overcomesthe disadvantages associated with the Herbert bone screw, as well asother prior art bone screws.

SUMMARY OF THE INVENTION

A bone screw for drawing together bone fragments separated by a fractureincludes a root portion having a leading end and a trailing end. Theleading end has a smaller diameter than the trailing end. A screw threadis formed on the root portion between the leading and trailing ends andhas a pitch which varies along the length thereof, having a larger pitchnear the leading end and a smaller pitch near the trailing end. Thethread is adapted to thread in the cancellous material of the respectivebone fragments to be joined by the screw. Means are provided on thetrailing end of the root portion to accommodate a tool for driving thescrew. The present invention also contemplates a method for drawingtogether bone fragments separated by a fracture.

The foregoing and other objects, features and advantages of theinvention will become more readily apparent from the following detaileddescription of a preferred embodiment which proceeds with reference tothe drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an enlarged side elevation view of a bone screw constructed inaccordance with the present invention;

FIG. 1A is a view of the screw of FIG. 1 shown partially in crosssection;

FIG. 2 is an end view of the bone screw of FIG. 1;

FIG. 3 is a drawing illustrating the outside diameter of the screw;

FIG. 4 is a drawing illustrating the diameter of the root portion of thescrew;

FIG. 5 is a cross-sectional view of a bone screw constructed inaccordance with the present invention installed in a bone to draw afracture together;

FIG. 6 is a side elevation view of a bone screw constructed inaccordance with the present invention which may be used forinterphalangeal joint arthrodesis;

FIG. 7 is a view of the bone screw of FIG. 5 installed in a distalinterphalangeal joint with the bones forming the joint as shown incross-section;

FIGS. 8A–14D show the operation of various screws to compress two bonefragments together;

FIGS. 15A–D show the operation of a screw constructed according to analternative embodiment of the present invention to compress two bonefragments together;

FIGS. 16A–B are detailed views of the screw shown in FIGS. 15C and 15D,respectively;

FIG. 17A is a side elevation view of a bone screw constructed accordingto an alternative embodiment of the present invention;

FIG. 17B is a representation of the side profile of a root portion ofthe screw of FIG. 17A;

FIG. 17C is a representation of the outside diameter of the screw ofFIG. 7A;

FIG. 18A is a side elevation view of a bone screw constructed accordingto a fourth embodiment of the present invention;

FIG. 18B is a representation of the side profile of a root portion ofthe screw of FIG. 18A;

FIG. 18C is a representation of the outside diameter of the screw ofFIG. 8A;

FIG. 19 is an enlarged side elevation view of a bone screw constructedin accordance with an alternative embodiment of the present invention;

FIG. 19A is a view of the screw of FIG. 19 shown partially in crosssection;

FIG. 20 is an end view of the bone screw of FIG. 19;

FIG. 21 a illustrates the outside diameter and root profile of analternative embodiment of the present invention; and

FIG. 21 b is an elevational view of the screw of FIG. 21 a.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Indicated generally at 10 in FIGS. 1 and 1A is a bone screw constructedin accordance with the present invention. Bone screw 10 is centered on alongitudinal axis 11. The length of screw 10 as measured along axis 11is 0.394 inches in the present embodiment of the invention. The bonescrew includes a root portion 12 having a continuous screw thread 14formed thereon.

Root portion 12 includes a leading end 16 and a trailing end 18. As canbest be seen in FIG. 4, the diameter of leading end 16 is less than thediameter of trailing end 18. Also in FIG. 4, it can be seen that rootportion 12 tapers between trailing end 18 and leading end 16. A 45°bevel 20, in FIGS. 1 and 1A, is formed on trailing end 18. In thepresent embodiment of the invention, trailing end 18 has a diameter ofapproximately 0.092 inches. A frusto-conical nose portion 22 is formedon leading end 16 of root portion 12.

Screw thread 14 extends continuously between nose portion 22 and bevel20. As can be seen in FIGS. 2 and 3, a trailing thread 24 has a crestheight, i.e., the distance between axis 11 and a crest 26 of trailingthread 24, which varies so as to form a substantially 45° angle,illustrated as angle 28 in FIG. 3, between the outside diameter of crest24 and axis 11.

A similarly tapering leading thread 30 also has a crest 32 which variesin height over a first partial turn of screw thread 14 so as to form anangle of substantially 45° with axis 11 as illustrated in FIG. 3.

The crest of screw thread 14 between trailing and leading threads 24, 30respectively, varies in height along the length of thread 14. In thepresent embodiment of the invention, the outside diameter defined by thecrest of thread 14 between the leading and trailing threads forms anangle 34, in FIG. 3, of approximately 1.43° with respect to an axis 35extending from the radially outermost portion of thread 14 parallel toaxis 11. In the present embodiment of the invention, the diameter of theradially outermost portion of thread 14 is approximately 0.138 inches.

The pitch of thread 14, i.e., the distance from one point on the threadto the corresponding point on an adjacent thread measured parallel toaxis 11, decreases between the leading and trailing ends of the screw.It should be noted that the term pitch is also sometimes used to referto the number of threads per unit length, i.e., 20 threads per inch.This alternative definition is simply the inverse of the definitionchosen for use in this application. The distinction is important toremember for proper understanding of the subsequent description becausethe screw of the present invention relies on varying pitch to achieveits function.

In the embodiment of the invention shown in FIGS. 1 and 1A, the distancebetween the uppermost portion of crest 32 and a corresponding crestportion 36 is 0.04964 inches. The distance between the uppermost portionof crest 26 and a corresponding crest portion 38 is 0.04748 inches. Inthe present embodiment of the invention, the pitch change per revolutionis approximately 0.00036 inches.

The pitch depth, i.e., the distance between the crest and the radiallyouter surface of root portion 12 similarly varies along the length ofthe screw. In the present embodiment of the invention, the pitch depthwhere leading thread 30 joins the remainder of screw thread 14 isapproximately 0.0302 inches. The pitch depth where trailing thread 24joins the remainder of thread 14 is approximately 0.0240 inches.

The decrease in pitch depth between the leading end and trailing end ofthe screw can be seen by comparing FIG. 3 and FIG. 4 wherein rootportion 12 tapers more sharply from the trailing to the leading end ofthe screw than does the change in crest height as shown in FIG. 3. Inthe present embodiment of the invention, the outside diameter of rootportion 12 between leading and trailing ends, 16, 18, respectively,forms an angle 40, in FIG. 4, of approximately 2.5° with respect to anaxis 42 extending from the radially outermost portion of trailing end 18parallel to axis 11.

A hex socket 44 is formed on the trailing end of screw 10 to accommodatea driver as will be hereinafter further explained in connection with adescription of the procedure in which the screw is used to draw opposingfragments of a fractured bone together.

An alternative embodiment of the screw of the present invention is showngenerally at 410 in FIGS. 19 and 19A. Screw 410 includes a root portion412 on which is formed a thread 414. Thread 414 extends from a leadingend 416 to a trailing end 418 and includes a land 474. The pitch ofthread 414 at the leading end is 0.055 inches and the pitch at thetrailing end is 0.035 inches. The land varies from 0.010 inches to 0.004inches overt the same range. Thread 414 includes a cutting flute 415near the leading end to facilitate the cutting of female threads as thescrew is installed. Both the outside diameter of thread 414 and root 412taper from a smaller value at the leading end to a larger value at thetrailing end. See FIGS. 21–22. The root diameter tapers from 0.062inches to 0.122 inches, while the outside diameter tapers from 0.130inches to 0.156 inches. The length of screw 410 is 0.689 inches.

Screw 410 also includes an axial bore 425 which extends from the leadingend to the trailing end. Bore 425 is adapted to receive a stiff guidewire, not shown, which facilitates installation of screw 410. A hexsocket 444 is formed at the trailing end to allow the screw to be drivenby an hex wrench. See FIG. 20.

Turning now to FIG. 5, illustrated therein is a fracture 46 whichseparates adjacent bone fragments 48, 50. Screw 10 is illustratedinstalled in a bore 52 which extends through bone fragments 48, 50across fracture 46.

In installing screw 10, a surgeon first drills bore 52 across bonefragments 48, 50 as shown. The bit may be a conventional cylindricalbone bit or may comprise a bit having a slight taper from the leading tothe trailing end thereof. Thereafter, the surgeon inserts a tool (notshown) having a hex driver extending therefrom which is connectable tohex socket 44 for screwing screw 10 into bore 52. Bore 52 is of a sizeto just receive leading end 16 of screw 10. As soon as nose portion 22is received within the bore, torque is applied using the tool insertedinto hex socket 44 thereby causing leading thread 30 to cut into thebone adjacent bore 52.

In the view of FIG. 5, screw 10 is hatched to show the path cut byleading thread 30 after screw 10 is installed in the positionillustrated in FIG. 5. The path of thread 30 is depicted using hatching,like hatching 54, 56, 58 which indicates the position of the path cut byleading thread 30 relative to succeeding threads of the screw. Hatching60 depicts the actual position of the thread on screw 10 and root 12. Itis to be appreciated that hatching 54, 60 are not used in FIG. 5 todepict different structure, which is unitary as illustrated in FIG. 1,but to depict relative positions of the path cut by leading thread 30 inthe actual position of subsequent threads in the installed screw.

Because of the decreasing pitch along the length of the screw, eachsuccessive thread received in the path cut by thread 30 exerts pressureagainst the right side (as viewed in FIG. 5) of the path cut by thread30 thereby tending to compress the bone along the length of the screw.As can be seen in FIG. 5, by the time the screw is fully installed,trailing thread 24 compresses a substantial amount of bone when it isreceived in the path cut by thread 30. This tends to draw bone fragments48, 50 tightly together across fracture 46 thereby promoting healing ofthe fracture.

As can be appreciated from the view of FIG. 5, the thread taper isimportant for two reasons. First, each succeeding portion of the threadis spaced further radially outwardly as a result of the taper andtherefore the outer portion of each thread (that portion closelyadjacent the crest) cuts into new bone which was not cut by thepreceding thread. This provides a much better purchase than would athread having a continuously varying pitch with constant diameter. Insuch a configuration, each succeeding thread cuts additional bone withinthe generally cylindrical volume defined by the outside diameter of thethreads. The outer portion of each thread (that portion closely adjacentthe crest) therefore cuts into bone uncut by the preceding thread.

The tapered root is also advantageous in that the radially outer surfaceof the root, i.e., that portion between adjacent threads, is tightlyurged against uncut bone defining the wall of bore 52. It is desirableto maximize the surface area of screw 10 urged against adjacent bone,rather than a space cut by a thread, to increase purchase of the screw.

The details of the operation of the screw of the present invention, ascurrently understood, may be better appreciated by examination of FIGS.15A–D and FIGS. 16A–B and the following description. FIGS. 15A–Dillustrate the operation a screw 310 to draw together and join bonefragments 348 and 350. FIG. 15A shows screw 310 partially installed in abore 349 in bone fragment 348. Screw 310 is shown just entering a bore351 in bone fragment 350 in FIG. 15B. Subsequent rotation of screw 310starts the process of drawing the bone fragments together as shown inFIGS. 15C–D.

FIG. 16A shows the interaction of a thread 314 in bores 349 and 351 whenscrew 310 is positioned therein as shown in FIG. 15C. In FIG. 16A aleading end 316 of screw 310 is engaged in bore 349. Each revolution ofthe thread 314 is labelled for reference in the subsequent discussion,from thread T1 at the leading end to thread T23 at the trailing end.

As the screw moves through bone fragments 348 and 350, thread 314 willcut a mating female thread 353. However, because the pitch of thread 314changes along the length of the screw, female thread 353 will notprecisely match thread 314 of screw 310 along its entire length. Inparticular, since subsequent threads will not track in the same path asthe preceding threads, a pattern of leading gaps 355 and trailing gaps357 will evolve between female thread 353 and screw thread 314 as thescrew moves forward in the bores.

The screw will move forward in the bone fragment with rotation at a ratethat is a function of the competing forces from all of the threadsengaged in the bore. The rate will correspond to an effective pitch ofthe threads in the bore and will be equal to the pitch of the screw atan effective pitch point 359 along the portion of the screw engaged inthe fragment. As more of the screw enters the bore, the effective pitchpoint will move back along the screw and further into the bone fragment.Once the screw extends completely through the bone fragment, thelocation of the effective pitch point will stabilize at a relativelyconstant location in the bone fragment, simply moving back along thescrew at the rate the screw moves forward in the bore. The threads aheadof the effective pitch point, which will be referred to as the pullingthreads 371, will have greater pitch than the effective pitch.Similarly, the threads behind the effective pitch point, or draggingthreads 373, will have a pitch that is smaller than the effective pitch.In FIG. 16A the pulling threads in fragment 348 are T₁–T₄ and thedragging threads are T₅ and T₆.

Each rotation of the screw will move it forward in fragment 348 by anamount corresponding to the present value of the effective pitch. InFIG. 16A the effective pitch will be equal to the pitch of thread 314between threads T₄ and T₅. Starting at the leading end, thread T₁, willalways be cutting a new thread path in the fragment, so no gap will formaround it. Thread T₂, however, will attempt to follow the track ofthread T₁, in fragment 348, which would carry it forward by an amountequal to the pitch between thread T₁, and T₂. Since, however, the screwwill only move forward by the effective pitch, i.e., the pitch betweenthreads T₄ and T₅, thread T₂ can only move forward by the same amount.This causes thread T₂ to pull back against the surrounding bone andcreates a leading gap in front that thread. Similarly, thread T₃ willattempt to move into the position of thread T₂, but will be held backfrom moving as far forward as its pitch would indicate, thus creating aleading gap as thread T₃ is pulled back against the surrounding bone.Behind the effective pitch point, thread T₆ will attempt to move intothe prior position of thread T₅, but will be dragged forward somewhat,leaving a trailing gap.

The pattern of leading and trailing gaps created by screw 310 in bonefragment 350 is also shown in FIG. 16A. Bone fragment 350 includesleading gaps 361 and trailing gaps 363 similar to those found in bonefragment 348. However, because more of the screw has moved through bonefragment 350, the gaps have evolved to a greater extent. The earlierposition of screw 310 in fragment 350 is shown in dotted lines in FIG.16A to illustrate the evolution of the threads as the screw movesforward.

In the earlier position of screw 310, the effective pitch point falls atapproximately thread T₈. With the screw positioned as shown, theeffective pitch point is at approximately thread T₁₆, the screw havingcompleted approximately 8 revolutions between the two positions. Thecurrent and prior screw positions are aligned at effective pitch point367 in fragment 350 based on the assumption that thread 314 will trackthrough this point uniformly. The evolution of the position of threadsbehind and ahead of the effective pitch point can thus be seen bycomparing the prior position with the current position.

Leading gaps 361 have a sloping upper surface 365, which is a result ofthe gradual expansion of the outside diameter of thread 314 toward thetrailing end of the screw. Upper surface 365 represents a line from theprior position of the thread to the position as shown. As thread 314 ata given point in the bone fragment is held back, it simultaneouslyexpands in diameter. This effect prevents thread 314 from completelyreaming out the female thread in the bone fragment, as discussed above.Without the taper, sloping upper surface 365 would be flat and as soonas the width of the gap grew to equal the spacing between the threads,there would be no purchase left for subsequent threads along a portionof the bore.

Once the leading end of screw 310 has passed through bone fragment 351the effective pitch point remains at a relatively constant positionalong the bore for the remainder of the screw. If the pitch change perrevolution is dP and the effective pitch points are separated by Nthreads, then the bone fragments will be drawn together by a distance Ntimes dP for every revolution of the screw. In screw 310, dP=0.0008inches and the effective pitch points are separated by approximately 11threads, therefore the gap between the bone fragments will close byabout 0.009 inches per revolution.

It is thought that the effective pitch point will be somewhat behind thegeometric middle of the portion of the screw engaged in the bore asshown in FIG. 16A. Because bone becomes less dense near the center inthe cancellous portion, the threads nearer to the surface in the cortexare expected to have greater effect. Also, the threads nearer thesurface are of larger diameter because of the taper in the outsidediameter of the thread.

The other factor tending to cause the pitch point to be closer to thesurface of the bone relates to balancing the amount of bone displaced asthe leading and trailing gaps are formed. As shown in FIG. 16A, thepulling threads 371, which have pitch greater than the effective pitch,are held back from moving as far forward with each rotation as theirpitch would indicate. Likewise, dragging threads 373 are drawn forwardfaster than their pitch would dictate. This effect creates leading gaps355 in front of pulling threads 371 as they pull against the surroundingbone. Similarly, trailing gaps 357 form behind dragging threads 373 asthey are dragged forward through the surrounding bone.

Since the leading and trailing gaps are formed in opposition to oneanother, it is reasonable to assume that they will evolve at arelatively balanced rate. Combining this assumption with the fact thatthe effective pitch point is constantly moving forward in the bonefragment as the screw enters, suggests that the effective pitch pointwill be behind the geometric middle of the portion of the screw in thebone fragment. Because the effective pitch point is moving forward inthe bone fragment by approximately one-half the pitch change perrevolution, the dragging threads will be dragged forward byapproximately an extra one-half the pitch change per revolution for eachrevolution of the screw. The fact that the effective pitch point ismoving forward means that the pulling threads are not held back as muchas would be the case if the effective pitch point remained constant. Ifthe movement of the two thread regions through the bone are balanced,then the effective pitch point will not move forward in the bonefragment as rapidly as would otherwise be expected and the effectivepitch point will lie behind the geometric middle.

FIG. 16B shows how the pattern of gaps changes once the two bonefragments have been drawn together. After the bone fragments meet, thepattern of gaps starts to evolve toward that found in a single fragment.In particular, gaps form or increase on the leading side of all of thepulling threads ahead of an effective combined pitch point 369, and onthe trailing side of all the dragging threads behind the effectivecombined pitch point. Near the joint between the fragments, the gapswill generally transition from leading to trailing and vice versa,because the dragging threads in fragment 348 near the joint areconverted to pulling threads after the joint closes. The pulling threadsin fragment 350 likewise become dragging threads after the fragmentsmeet.

Rotation of screw 310 after the bone fragments have come together tendsto increase the pressure in the joint between them. Additional rotationcan be used to set the depth of the screw as desired. Since the outsidediameter of the thread tapers, as described above, the screw can bedriven in until the trailing end is below the surface of the bonewithout danger of stripping the female thread formed by the precedingthreads, even if the bone fragments first meet with the trailing endprotruding substantially. This is because subsequent threads expand andcut into some new bone even as they partially ream the female threadsleft by preceding threads on the screw. This is in contrast to theHerbert screw, where, as discussed above, additional tightening afterthe fragments have come together can strip out the threads in the distalfragment and reduce compression. Since it is important in the preferredapplication of the present invention to have the trailing end of thescrew below the surface of the bone, this is an important feature andadvantage over prior art screws.

The tolerance in the screw of the present invention to furthertightening after the fragments have come together is also importantbecause it simplifies the installation process by eliminating the dangerof over-tightening that must be guarded against when using the Herbertscrew.

Turning now to FIG. 6, indicated generally at 62 is a second embodimentof a bone screw constructed in accordance with the present invention.Bone screw 62 is sized and constructed for use in connection withinterphalangeal joint arthrodesis. Screw 62 includes a tapered root 64having a thread 65 formed thereon from a leading end 63 to a trailingend 67, a substantially cylindrical leading extension 66 joined to theleading end and a substantially cylindrical trailing extension 68 joinedto the trailing end. The diameter of leading extension 66 is slightlylarger than root 64 at leading end 63, while the diameter of trailingextension 68 is slightly smaller than root 64 at trailing end 67. Thetrailing extension 68 includes a hex socket (not visible), like hexsocket 44 in FIG. 1A, formed on an end surface 70 thereof. Leadingextension 66 includes a tapered nose 72 formed on the forward endthereof. In the present embodiment of the invention, screw 62 is 1.259inches in length with the threaded portion being 0.630 inches long andthe diameter of leading extension 66 being 0.05 inches. The trailingextension diameter is 0.100 inches. As is the case with the previouslydescribed embodiment, the pitch of thread 65 decreases between theleading and trailing ends. In the embodiment of FIG. 6, a land 74 isformed in the crest of thread 65 and decreases in width between theleading and trailing ends of the screw.

Turning now to FIG. 7, a distal phalanx 76 comprises the outermost boneof one of the four fingers. A proximal phalanx 78 is adjacent theretowith a distal interphalangeal (DIP) joint 80 being formed therebetween.

The joint includes a pair of articular surfaces 82, 84 which have beenflattened in accordance with a known technique for immobilizing DIPjoint 80. Bores 86, 88 are drilled into each of phalanxes 76, 78 fromarticular surfaces 82, 84, respectively. Thereafter the bones arerepositioned as shown in FIG. 7 and screw 62 is driven into the distalend of the bore in phalanx 76 until the screw is positioned as shown inFIG. 7.

Screw 62 thus compresses across joint 80 even though it has a relativelysmall diameter, which is critical in DIP joint arthrodesis because ofthe small diameter of the bones involved. Screw 62 also has sufficientlength, due to the leading and trailing extensions 66, 68, to providestability while the bones are fusing. Because the screw is entirelyreceived within the bones, i.e., there is no protrusion from the screw,it can remain implanted and thus a second procedure to remove the boneis not necessary.

A third embodiment of a screw constructed according to the presentinvention is shown generally at 110 in FIG. 17A. Screw 110 includes aroot portion 112 on which is formed a continuous screw thread 114 andassociated land 174. Screw 110 includes a leading end 116 and a trailingend 118. Leading cutting flutes 115 are formed in thread 114 nearleading end 116 to help the thread self tap into the bone. A series oftrailing cutting flutes 117 are formed in thread 114 along the sides ofthe screw toward the trailing end. Trailing cutting flutes 117facilitate installation and removal of the screw by helping to cut athread path in the bone. Screw 110 may be formed with two sets oftrailing cutting flutes, one oriented to cut female threads uponinsertion and another oriented to cut female threads upon removal of thescrew, thus easing both installation and extraction. A hex socket 144 isformed in the trailing end of screw 110 to receive a drive tool.

Screw 110 is formed with a variable pitch portion 119 and a constantpitch portion 121. Variable pitch portion 119 extends from leading end116 back toward trailing end 118 for about 70 percent of the length theof the screw. The length of the screw is 0.961 inches. It should benoted that screw 110 does not include a bevel at the trailing end asformed on screw 10 and shown at 20 in FIG. 1A. The bevel was eliminatedin screw 110 to provide additional structural support around hex socket144 which is used for driving the screw.

Variable pitch portion 119 of screw 110 is formed according to thepreviously described construction of screw 10. In particular, the pitchof thread 114 is largest at leading end 116 and decreases over variablepitch portion 119 back toward trailing end 118. The pitch starts at0.050 inches and decreases to 0.0365 inches at the trailing end of thevariable pitch portion. As shown in FIG. 17B, root portion 112 tapersoutward from leading end toward trailing end over variable pitch portion119 with an angle 140 of 1.93° relative to the longitudinal axis of thescrew. The diameter of the root portion is 0.032 inches at the leadingend and 0.091 inches at the trailing end. The outside diameter of threadincreases over the same region at an angle 134 of 1.0°. See FIG. 17C.The outside diameter of the thread at the leading end is 0.077 inchesand 0.1 inches at the trailing end.

The construction of constant pitch portion 121 is considerably differentfrom that of variable pitch portion 119. The pitch and outside diameterof thread 114 are constant over the section of the screw formingconstant pitch portion 121. Root portion 112 continues to taper outwardrelative to the axis of the screw but at a lesser angle 127 of 1.57°over the constant pitch portion. The width of land 174, i.e., the flatat the crest of the thread, which decreases from the leading end overthe variable pitch portion, increases over the length of the constantpitch portion toward the trailing end. Land 174 starts at the leadingend at 0.008 inches and decreases to 0.002 inches at the end of thevariable pitch region. Land 174 starts to increase again moving backover the constant pitch portion, reaching a value of 0.006–0.007 inchesat the trailing end.

The constant pitch portion at the rear of screw 110 allows constructionof a longer screw without the commensurate increase in diameter thatwould occur by extending the structure of the variable pitch portion.This is important where the screw is to be used in small bones thatcannot accept a larger bore, but which require a longer screw. A longerscrew may be required to reach deeper fractures or for use in fusing twobones together. Screw 110 is particularly suitable for use in distalinterphalangeal fusions in the hand as described above.

A fourth embodiment of a screw constructed according to the presentinvention is shown at 210 in FIG. 18A. Screw 210 is generally similar toscrew 110 of FIG. 17A, and includes a root portion 212, a thread 214, aleading end 216 and a trailing end 218. Screw 210 also includes avariable pitch portion 219 and a constant pitch portion 221. See FIG.18B. The diameter of root portion 212 tapers at an angle 240 of 2.29°from 0.050 inches at the leading end to 0.106 inches at the trailingend. The outside diameter of thread 214 tapers at an angle 234 of 1.2°from 0.110 inches to 0.140 inches over the same range. The overalllength of screw 210 is 0.787 inches.

The principal difference between screws 110 and 210 is found in theconstant pitch portions. In screw 210, neither the root portion nor theoutside diameter of the thread is tapered in the constant pitch region.See FIG. 18B–C. Screw 210 is designed, like screw 110, to haveadditional length without additional thickness. If additional length isdesired, it is possible to form screw 210, or screw 110, with leadingand/or trailing extensions such as found on screw 62 in FIG. 6.

Thread 214 on screw 210 includes a land 274. Land 274 starts at amaximum of 0.007 inches at the leading end and decreases to 0.003 inchesat the trailing end. In contrast to screw 110, land 274 does notincrease over the constant pitch portion. Thread 214 also includesleading cutting flutes 215 and trailing cutting flutes 217 to facilitateinstallation and removal.

Screw 210 also varies from screw 110 in that it includes an axial bore225. Axial bore 225 permits screw 210 to be guided into the bone on astiff wire to facilitate positioning and prevent the screw fromwandering off axis as it is driven in.

A screw according to the present invention particularly adapted for usein ankle fusions is shown generally at 410 in FIGS. 21 a–b. Screw 410includes a root portion 412 that tapers at a constant rate from aleading end 414 to a trailing end 416. In the preferred embodiment theroot has a length of 2.383-inches and tapers from a radius of0.184-inches near the trailing end to a radius of 0.098-inches near theleading end.

A screw thread 418 is formed on root portion 412 and extends from theleading end to the trailing end thereof. Thread 418 has a thread crest420 at its radial outermost edge. As with the previously describedembodiments, the thread is terminated at the leading end and trailingend with a 45-degree taper. Thread 418 has a pitch measured betweenconsecutive thread crests which varies between a larger value near theleading end to a smaller value near the trailing end. Preferably, thepitch changes uniformly between the ends from a value of 0.097-inches atthe leading end to a value of 0.066-inches at the trailing end.

In contrast to the previously described screws, screw 410 has a guidetaper 422 at the leading end of the root portion. The guide taper has ataper angle of approximately 15-degrees and serves to help maintain theleading end of the screw centered in the pilot hole in the bone in whichit is installed. The guide taper extends along the root portion backfrom the 45-degree taper for a distance of 0.129-inches.

Screw 410 has a region 424 of constant outside diameter that extendsback from the guide taper for a length of 0.090-inches with a diameterof 0.205-inches. A second region 426 of constant diameter is disposedadjacent the trailing end of the screw with a diameter of 0.256-inchesfor a length of 0.197-inches. Provision of regions 424 and 426 allowsscrew 410 to have a long length while reducing the amount of taper thatwould otherwise be required. It is important to maintain the radius aslarge as possible near the lead end to obtain adequate grip in thisregion. This is particularly important in the preferred application forscrew 410 of ankle fusions because the amount of screw 410 engaged inthe tibia may be limited. It is likewise important not to make theradius at the trailing end any larger than necessary to minimize thesize of the hole required. The region of constant diameter at thetrailing end is also important because it provides a region for grippingthe screw during manufacture. Between the regions of constant diameteris a central region 428 in which the pitch and diameter of the screwchange together. The central region has a length of 1.870-inches in thepreferred embodiment.

A significant difference between screw 410 and the previously describedembodiment lies in the formation of the threads. In particular, in thepreviously described embodiments, the screw thread is cut with a toolwith a flat face and outwardly sloping sides. In the previousembodiments, the width of the face determines the spacing between thethreads on the root portion, which was therefore constant along thelength of the screw. By pulling the tool back from the axis of the screwand adjusting the pitch properly, the thread can be cut with a varyingpitch and depth. However, with each pass of the tool along the screw,the tool follows the same longitudinal path in the thread but simplycuts closer to the root portion. The land at the crest is also increasednear the leading end to allow for additional pitch gain near the leadingend while maintaining a decreasing outside radius.

In screw 410, in contrast, the longitudinal position of the tool alongthe root portion is changed from pass to pass as the screw is beingturned. In particular, in one pass down the screw thread, the toolfollows a first path. In a subsequent pass the tool is shiftedlongitudinally along the screw slightly at the same depth to increasethe width of the inter-thread distance 428 on the root toward theleading end. Cutting the thread in this fashion allows a sharper threadto be produced while still obtaining the desired outside diameter taperand pitch variation. Sharper thread is beneficial because it leaves asmaller track in the bone which leaves more bone for subsequent threadsto grip and makes the screw easier to drive in during installation. Aswith previously described embodiments, it is important that the radiusand depth of the threads near the leading end be sufficient to provide agrip on the bone which is comparable to the grip of the threads near thetrailing end of the screw.

It should be understood that screw 410 could be manufactured in avariety of lengths to accommodate different size patients. Moreover, forshorter screws, the region of constant outside diameter near the leadingend may be eliminated without unduly compromising the grip of theleading threads. It should also be noted that shorter screws willtypically taper at a greater angle.

In the actual fusion, a hole is drilled up from the heel through thecalcaneous and talus and into the distal end of the tibia. The screw isthen driven into the hole to draw the three bones together. With time,the pressure generated by the screw leads to fusion of the bones. Thepresent screw is advantageous for this operation because it can bemounted sub-surface since it does not have a head. Furthermore, thescrew offers excellent grip and controllable compression when comparedwith standard lag screws.

Although not shown in FIGS. 21 a–b, screw 410 preferably is cannulatedto provide improved stability during installation.

It should be noted that the length, number of threads, pitch, pitchchange per revolution and the various diameters are not critical to thepresent invention and can be varied without departing from the spirit ofthe invention. Such parameters are chosen to suit the particular use towhich the screw is applied.

While the invention has been disclosed in its preferred form, thespecific embodiments thereof as disclosed and illustrated herein are notto be considered in a limiting sense because numerous variations arepossible. Applicant regards the subject matter of his invention toinclude all novel and non-obvious combinations and subcombinations ofthe various elements, features, functions, and/or properties disclosedherein. No single feature, function, element, or property of thedisclosed embodiments is essential. The following claims define certaincombinations and subcombinations which are regarded as novel andnon-obvious. Other combinations and subcombinations of features,functions, elements, and/or properties may be claimed through amendmentof the present claims or presentation of new claims in this or a relatedapplication. Such claims, whether they are broader, narrower, or equalin scope to the original claims, also are regarded as included withinthe subject matter of applicant's invention.

1. A method of forming a bone screw, comprising: selecting a body member having a shank; cutting the shank so that a thread of varying pitch is formed during a first pass along the body member; and thinning the thread during a second pass along the body member.
 2. The method of claim 1, wherein the step of cutting forms a root of the thread, and wherein the step of thinning widens the root.
 3. The method of claim 1, the steps of cutting and thinning being performed with a tool, wherein the tool follows a first path during the step of cutting, and wherein the tool follows a second path shifted longitudinally from the first path during the step of thinning.
 4. The method of claim 3, the tool having a flat face, wherein the steps of cutting and thinning are performed so that the flat face cuts the shank to form a root of the thread.
 5. The method of claim 3, wherein the shank has a long axis and the thread has a depth, and wherein the tool is disposed at the same depth during the steps of cutting and thinning.
 6. The method of claim 3, wherein the shank has a long axis and the thread has a depth, and wherein the tool is disposed at a varying distance from the long axis during the step of cutting to vary the depth.
 7. The method of claim 1, wherein the step of cutting forms a crest of the thread, and wherein the step of thinning narrows the crest.
 8. The method of claim 1, wherein the step of cutting forms a root of the thread, the root defining an inter-thread distance between a leading edge and a trailing edge of the root, and wherein the step of thinning increases the inter-thread distance toward the leading edge of the root.
 9. The method of claim 1, wherein the step of cutting forms a thread that extends at least substantially to opposing ends of the body member.
 10. The method of claim 1, wherein the step of selecting a body member selects a body member having an axial bore. 